Are the Kids All Right? FDA Warning Letters Put FDA in a Bind

On December 16, CDRH issued 12 Warning Letters to manufacturers and retailers of breast binders.  The Warning Letters were posted on FDA’s website 2 days later. According to the Warning Letters, the products offered by these companies are intended to compress breast tissue and create a flatter chest appearance. Moreover, for FDA jurisdictional purposes, the Warning Letters claim that, because the targeted companies were marketing these products to alleviate gender dysphoria, they are medical devices.  Furthermore, the Warning Letters claim the devices were misbranded, in violation of the Federal Food, Drug, and Cosmetic (FD&C) Act, because the companies did not register their establishments or list their devices with FDA.

Are these products devices?

We’ll get the easy stuff out of the way first. To the extent that FDA could prove that a company marketed a breast binder to treat or mitigate a disease or condition or to affect a structure or function of the body, it could show that the product would meet the statutory definition of a medical device.  FDA classifies therapeutic medical binders, including breast binders, as Class I medical devices under 21 C.F.R. § 880.5160.  A therapeutic medical binder is “a device, usually made of cloth, that is intended for medical purposes and that can be secured by ties so that it supports the underlying part of the body or holds a dressing in place. This generic type of device includes the abdominal binder, breast binder, and perineal binder.”

Breast binders have been assigned product code HEF.  Like other therapeutic medical binders, they are exempt from 510(k) premarket notification requirements, as well as from most quality system regulation requirements (with the exception of complaint handling).  A breast binder intended for use in individuals with gender dysphoria, a psychiatric disorder as defined in the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition), would therefore meet the definition of a medical device.

Manufacturers of medical devices are required to register their establishments and list the products they manufacture with FDA.  The failure to register and list is a “misbranding” violation under the FD&C Act, 21 U.S.C. § 352(o).

Why would FDA issue these warning letters?

Here’s where things start to get a bit … odd.  It is rare for CDRH to issue a Warning Letter involving a low risk (i.e., Class I, 510(k) and QSR exempt) device.  Moreover, anyone who keeps up with Warning Letters would agree that it is highly unusual—indeed unprecedented— for the agency to issue a Warning Letter in response to a simple failure to register and list, a technical violation that can be remedied in a matter of minutes, involving only setting up an electronic account and paying a user fee.

For CDRH to issue a Warning Letter under these circumstances is inconsistent with FDA’s own policies. Chapter 4 of FDA’s Regulatory Procedures Manual (RPM) includes agency guidance and procedures for Warning Letters and Untitled Letters. Chapter 4-1-1 states:

The agency position is that Warning Letters are issued only for violations of regulatory significance. Significant violations are those violations that may lead to enforcement action if not promptly and adequately corrected. A Warning Letter is the agency’s principal means of achieving prompt voluntary compliance with the Federal Food, Drug, and Cosmetic Act (the Act).

In contrast, Chapter 4-2-1 describes Untitled Letters and when those may be appropriate:

An Untitled Letter cites violations that do not meet the threshold for significance of regulatory significance for a Warning Letter.

Separate from the RPM, FDA’s website also describes another type of CDRH communication, the “It Has Come to Our Attention” (IHCTOA) letter, which is used when CDRH has become aware that regulated industry may (emphasis in original) be promoting a device in a potentially violative manner.

The violations cited in the Warning Letters therefore do not support the agency’s response.  A failure to register an establishment and list a device—moreover a low-risk device—is unequivocally not a violation “of regulatory significance.” In fact, we are not aware of any other instance in which a Warning Letter was issued solely for the failure to register and list.  In part, this is because these violations can be corrected the same day that a manufacturer becomes aware of them.

If FDA were truly concerned solely about the failure to register or list, an IHCTOA or Untitled Letter would have been more appropriate, and consistent with established policy.  Importantly, IHCTOA and Untitled letters are, generally, non-public and allow companies to voluntarily come into compliance without shining a public light on them.  In our experience, FDA sends IHCTOA or Untitled Letters even for violations with far greater significance, such as marketing a device without 510(k) clearance.

Was FDA’s Concern Really About Registration and Listing?

A Warning Letter was clearly overkill in response to a failure to register and list, leading us to conclude that FDA’s concern was not really about registration and listing.  This conclusion is further supported by statements by FDA Commissioner Marty Makary made concomitantly with the issuance of the Warning Letters, alleging serious risks to children related to these products.  According to Dr. Makary, “Breast binders are a Class I medical device with legitimate medical uses such as being used by women after breast cancer surgery. These binders are not benign. Long-term usage has been associated with pain and compromised lung functions, and even difficulty breastfeeding later in life.”  Dr. Makary added that the Warning Letters will formally notify companies of these violations and will require prompt corrective actions. “Pushing transgender ideology in children is predatory, it’s wrong, and it needs to stop.”

The Commissioner made these statements during a press conference in which the Department of Health and Human Services (HHS) announced a series of proposed regulatory actions aimed at limiting access to gender-affirming care for minors, including a proposed rule from the Centers for Medicare & Medicaid Services (CMS) that would ban hospitals from performing sex change operations for children under 18.  A press release issued by HHS on the day of the press conference, titled, “HHS Acts to Bar Hospitals from Performing Sex-Rejecting Procedures on Children,” focused primarily on the CMS proposed rule, but mentioned the FDA Warning Letters, stating:

The U.S. Food and Drug Administration (FDA) is issuing warning letters to 12 manufacturers and retailers for illegal marketing of breast binders to children for the purposes of treating gender dysphoria. Breast binders are Class 1 medical devices used for purposes such as assistance in recovery from cancer-related mastectomy. The warning letters will formally notify the companies of their significant regulatory violations and how they should take prompt corrective action.

The press release uses the “significant regulatory violations” language presumably to support issuance of the Warning Letters, even though, as noted above, the only stated violations are the failure to register and list, which are not “significant regulatory violations.”

The press release included a quote by Commissioner Makary stating that “Illegal marketing of these products for children is alarming, and the FDA will take further enforcement action such as import alerts, seizures, and injunctions if it continues.”

The Warning Letters themselves, however, make no mention of any health risks associated with breast binders, calling into question the extent to which these statements by the Commissioner are supported by available facts and scientific evidence.  A review of MAUDE indicates there has not been a single reported adverse event associated with any breast binder in the last five years.  Furthermore, the scientific literature reflects a more nuanced view about the risks and benefits of breast binders (see, e.g., here). As with all products, there cannot be a focus on risk without also considering benefits, but Dr. Makary’s statements seem to dismiss altogether the benefits while exclusively emphasizing potential risks.

Additionally, the Warning Letters do not make any reference to “illegal marketing of breast binders to children,” as suggested by Dr. Makary.  We reviewed several of the websites for the companies that received Warning Letters, and did not see marketing specifically directed towards children. The statement in the press release about issuing the Warning Letters to protect children is therefore not supported by the language in the Warning Letters, or the marketing of the products themselves.

Furthermore, even if these companies were overtly marketing to children, they could easily discontinue such claims, if, in fact, such claims are violative; we note that the classification regulation encompassing breast binders does not restrict their use to adults.  If the marketing of the products is consistent with the regulatory definition of a therapeutic medical binder, which specifically includes breast binders, and the company complies with its other limited regulatory obligations, it is not clear on what basis FDA could claim that such marketing is “illegal” on its face.

Yet another oddity about these Warning Letters is that most of them also cc Shopify, which is presumably the platform through which the products are purchased and the transactions processed.  Although FDA has issued Warning Letters directly to Amazon for selling products that FDA deems adulterated and/or misbranded, copying the sales platform is, in our experience, unprecedented.  Whether FDA plans to take action against Shopify, and other platforms that facilitate sales of these products, remains unclear.

So what happens next?

Historically, FDA has taken the position that a “Warning Letter is informal and advisory. It communicates the agency’s position on a matter, but it does not commit FDA to taking enforcement action. For these reasons, FDA does not consider Warning Letters to be final agency action on which it can be sued.”  Courts have generally accepted that position, but past is not necessarily prologue.  The sellers of these products will need to decide how to determine whether they are in violation of the FDC Act and if so, how to come into compliance (in some form – either as devices or by making changes to not be devices). For a class I, 510(k) exempt product, this is relatively straightforward, although it would entail additional expenses, including an annual registration fee and costs associated with developing policies and procedures for complaint handling, MDR reporting, and corrections, removals, and recall handling.  Compliance with these requirements could, however, increase operating expenses for these companies which could, in turn, decrease accessibility for some who need them.

Alternatively, sellers of these products could change the claims to be esthetic in nature without mention of a specific medical disease or condition (e.g., gender dysphoria).  If that were the case, these binders would arguably not fall within the definition of a medical device at all.  However, given that therapeutic medical binders, including breast binders, have been classified as Class I, 510(k)-exempt devices for more than two decades, and that gender dysphoria is a recognized therapeutic use of breast binders, promoting the use of these products to alleviate gender dysphoria, which enables those who need  the products to more easily find them, would appear consistent with the classification regulation.

Given Dr. Makary’s statement in the press release that “FDA will take further enforcement action such as import alerts, seizures, and injunction if [marketing of these products for children] continues,” it is safe to assume that even if the companies come into compliance, this will not be the last we see of FDA enforcement related to these products.  FDA’s focus of the agency’s limited resources on a Class I device in the absence of serious safety signals, would be a strange prioritization, and inconsistent with the agency’s enunciated focus on reducing burdens on companies to speed availability and access to new products.  Moreover, any such effort would allow a targeted company another opportunity to challenge such an enforcement action as unlawful, under the FDC Act, the Administrative Procedure Act, and/or the U.S. Constitution.  In the face of such a challenge, FDA could be required to explain why it was not arbitrary and capricious or otherwise unlawful to target a company for allegedly marketing products to children when claiming that the violative conduct was the seemingly unrelated violation of failure to register.

In sum, these letters are yet another example of the seeming contradiction that is the current administration and FDA.  See our earlier post here.  On the one hand, Dr. Makary talks about patient access and lowering burdens to getting new products on the market, while on the other, these letters are clearly aimed at making access to these products more costly and difficult, which could mean that fewer patients in need will access them. More fundamentally, FDA may be called to explain why it is publicly targeting safe, low‑risk products that support those seeking treatment for gender dysphoria, and why the Warning Letters cite a technical, easily-corrected violation while the rhetoric in its press release alleges different concerns.